Becton Dickinson 3rd Edition T34™ Ambulatory Syringe Pumps mms-21-3999 (ICN 1284)
Important Customer Notice Field Safety Notice
Ref: 2021/1284 ICN Number: 1284
- Becton Dickinson (BD) has issued a Field Safety Notice to advise of a software upgrade for certain serial numbers of the 3rd Edition T34™ Ambulatory Syringe Pumps to enhance the battery life.
- Through customer feedback, BD has identified that the battery life of the 3rd Edition T34™ Ambulatory Syringe Pumps may not meet customer expectations and clinical workflow. As a result, BD has taken the decision to upgrade the 3rd Edition T34™ Ambulatory Syringe Pumps on the market to align with the battery life of the newly released BD Bodyguard T™ pump, refer to the table on page 1 of the Field Safety Notice.
- The battery life of the 3rd Edition T34™ Ambulatory Syringe Pumps is functioning as designed and as intended. The Directions for Use for the 3rd Edition pumps also describes the correct functioning. A potential risk exists if the User expects the device to function as a 2nd Edition T34™ Ambulatory Syringe Pump which has a longer battery life. This risk is expected to be low as in a hospital environment the Clinical User will be present and, in a homecare setting the infusions are mostly set up for 24 hours or less. The risk will be further mitigated through the software upgrade as the battery life of the pump will be increased, approximately x 2.
- The T34 syringe driver pump is available from NHS Supply Chain via our eDirect route, with a bespoke NPC created for each trust as required.
- Serial numbers within the range S00402878 and onwards are in scope of this software upgrade and will be issued a new version of the Directions for Use (DFU) once upgraded. Please refer to Appendix 1 for guidance on identifying the serial number on your 3rd Edition T34™ Ambulatory Syringe Pump.
- Ensure the contents of this Field Safety Notice are read and understood by those within your organisation who may use or service the 3rd Edition T34™ Ambulatory Syringe Pumps. If you have further distributed the pumps to other organisations, please identify those organisations and notify them at once of this Field Safety Notice.
- Complete the Customer Reply Form (Page 3) indicating whether you wish the software upgrade of the pumps to be performed by BD (Option 1) or by your organisation/service provider (Option 2) and return the completed form to BD at T34FieldAction@bd.com no later than 15 June 2021.
- If selecting Option 1, a BD representative will contact you upon receipt of your completed Customer Reply Form to discuss BD scheduling the software upgrade.
- If selecting Option 2, a BD representative will contact you upon receipt of your completed Customer Reply Form to discuss providing the instructions to conduct the software upgrade activity.
- All sites that receive the software upgrade will also receive new Directions for Use (DFU999-103BDEN) for the pumps.
- Once your pump receives the software upgrade, BD recommends destroying all previous version of the T34 3rd Edition DFU (DFU999-103EN) in your possession.
- Users can identify on the pump that the software has been upgraded as the display on the pump will display the new software version (per Figure 1 below).
Figure 1: Display of pump with updated software
- Should you have any questions about this please contact your local BD representative. Clinical training will be provided as part of the software roll-out to provide information on other pump changes implemented as part of the upgrade.
- If you experience any issues with the software following the pump upgrade, please contact email@example.com.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.